Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Fluticasone Furoate
Product Code: GW685698X
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: FLUTICASONE FUROATE
CAS Number: 397864-44-7
Current Sponsor code: G
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and pre-menarchial female subjects aged 5–11 years on the last planned treatment day are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less. 2. Diagnosis of asthma at least 6 months prior to screening. 3. Patients must be controlled on their existing asthma treatment at screening as defined by a Childhood Asthma Control Test score of >19 and PEF =80% predicted. 4. Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions. 5. Subjects must be taking a stable regimen of a short acting beta-agonist inhaler on an as-need basis for at least 4 weeks prior to screening. 6. Subjects must weigh at least 15 kg. 7. Subjects must demonstrate ability to accept and effectively use the fluticasone furoate devices using the demonstration kits provided to the site. 8. Subjects and parents/guardians must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must have the ability to read, write and record diary information collected throughout the study. They must also have the ability to manage study drug administration and PEF assessments. 9. A signed and dated written informed consent from at least one parent/guardian, and accompanying informed assent from the subject prior to admission to the study. Are the trial subjects under 18? yes Number of subjects for this age range: 26 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who have changed their asthma medication within 4 weeks of screening or subjects currently being treated with inhaled corticosteroids or have received such treatment within 4 weeks of screening. In addition, subjects currently receiving (or have received within 4 weeks of screening) any of the following asthma therapies: theophyllines, long-acting inhaled beta-agonists or oral beta-agonists. 2. Any medical condition or circumstance making the volunteer unsuitable for participation in the study (e.g. history of life-threatening asthma). 3. Any clinically relevant abnormality identified on the screening medical assessment, including asthma exacerbation requiring systemic corticosteroids (oral, intramuscular, intravenous) or emergency room attendance within 3 months or asthma exacerbation requiring hospitalization within 6 months prior to screening. 4. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study. 5. Clinical visual evidence of oral candidiasis at screening. 6. Parent/guardian has history of psychiatric disease, intellectual deficiency, substance abuse, or other condition (e.g., inability to read, comprehend and write) which will limit the validity of consent to participate in this study. 7. Any adverse reaction including immediate or delayed hypersensitivity to any beta-2- agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy. 8. Known or suspected sensitivity to the constituents of the novel dry powder inhaler (i.e., lactose or magnesium stearate), for example, history of severe milk protein allergy. 9. A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator. 10. Children who are wards of the state or government. 11. Evidence of clinically significant abnormality in the 12-lead ECG at screening, as follows: i. Ventricular rate 115 bpm if aged 5–7 years. ii. Ventricular rate 110bpm if aged 8–11 years. iii. PR interval >160 msec if aged 5–7 years. iv. PR interval >170 msec if aged 8–11 years. v. QRS >100 msec. vi. Evidence of Mobitz II second degree or third degree AV block. vii. Evidence of =2 unifocal ventricular ectopic beats, couplets, bigeminy, trigeminy or multifocal premature ventricular complexes on three ECG traces. viii. QTcB >450 msec or an ECG that is not suitable for QT measurements (e.g. poor defined termination of the T wave). ix. Right or left complete bundle branch block. x. Clinically significant conduction abnormalities (e.g. left bundle branch block, Wolff-Parkinson-White syndrome). xi. Clinically significant arrhythmias (e.g. atrial fibrillation, atrial flutter, ventricular tachycardia). xii. Non-sustained VT (3 or more consecutive ventricular beats greater than 100 bpm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability following administration of fluticasone furoate 100 µg (via a novel dry powder inhaler) once daily for 14 days in 5–11 year-old subjects.;Secondary Objective: • To characterize the pharmacokinetics of fluticasone furoate 100 µg (via a novel dry powder inhaler) once daily for 14 days in 5–11 year-old subjects. • To determine the effects of administration of fluticasone furoate 100 µg (via a novel dry powder inhaler) once daily for 14 days in 5–11 year-old subjects on serum cortisol.;Primary end point(s): •Adverse events. •Clinical laboratory assessments (hematology, chemistry and urinalysis). •Peak expiratory flow on Day 1 (0–2 h) and Day 14 (0–12 h). •Systolic blood pressure (BP) and diastolic blood pressure. •Heart rate. •Electrocardiographic (ECG) parameters: QT duration corrected for heart rate by Fridericia’s formula (QTcF). ;Timepoint(s) of evaluation of this end point: •Adverse events from start of investigational product until follow up contact. •Clinical laboratory assessments at screening and pre-dose on Day 14 •Peak expiratory flow at screening and on Day 1 and Day 14 in the clinic and on Days 1-13 at home •Systolic and diastolic blood pressure at screening, Day 1 and Day 14 •Heart rate and ECG at screening, Day 1 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Fluticasone furoate maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments AUC(0-t), AUC(0-12) and time of occurrence of Cmax (tmax) on Day 14. •Serum cortisol weighted mean (0–12 h) on Day 14. ;Timepoint(s) of evaluation of this end point: •Fluticasone Furoate on Day 14 •Serum cortisol on Day 14 | — |
Countries
United States
Contacts
Public ContactGSK Clinical Support Helpdesk
GlaxoSmithKline
Outcome results
None listed